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KIDCARE (Kawasaki Disease Comparative Effectiveness Trial) (KIDCARE)

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ClinicalTrials.gov Identifier: NCT03065244
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jane C. Burns, University of California, San Diego

Brief Summary:
Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels (coronary arteries) of infants and children and is now the most common cause of acquired heart disease in children. A mixture of proteins from human blood (Intravenous immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20% of children are resistant to this treatment and the fever returns. These children have the highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately, there are no guidelines for the best secondary treatment for these resistant patients because the problem has never been adequately studied. Most physicians choose either a second infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that promotes inflammation. This trial will randomize (assign by chance like the flip of a coin) IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the response to treatment will be compared to learn which treatment stops the fever the fastest. In addition, parents and caregivers will provide observations about their child's response to the different treatments.

Condition or disease Intervention/treatment Phase
Mucocutaneous Lymph Node Syndrome Drug: IVIG Drug: Infliximab Phase 3

Detailed Description:

This is a 3-year (2.75-years of enrollment), Phase III, two-arm, randomized, multi-center, superiority treatment study to compare infliximab to a second intravenous immunoglobulin (IVIG) infusion for treatment of persistent or recrudescent fever in children with KD who fail to become afebrile after the first IVIG infusion.

  1. Specific aim 1 will test the hypothesis that infliximab will be superior to a second intravenous immunoglobulin (IVIG) infusion for treatment of persistent or recrudescent fever in children with KD who fail to become afebrile after the first IVIG infusion (resistant KD). Cessation of fever (<38°C rectally or orally) within 24h of initiation of study treatment infusion will be the primary outcome measure.
  2. Specific aim 2 will test the hypothesis that infliximab treatment will result in more rapid resolution of inflammation compared to second IVIG as measured by the change in white blood cell count (WBC), absolute neutrophil count (ANC), and high-sensitivity C-reactive protein (hsCRP) concentration between baseline and 24 hours and 2 weeks following study treatment.
  3. Specific aim 3 will test the hypothesis that infliximab treatment will result in a reduction from baseline in coronary artery Zworst score of ≥ 0.05 standard deviation units as compared to second IVIG at 2 weeks following study treatment measured by echocardiography.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Active Comparator: IVIG
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
Drug: IVIG
Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
Other Name: Intravenous immunoglobulin

Active Comparator: Infliximab
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Drug: Infliximab
Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
Other Name: Remicade




Primary Outcome Measures :
  1. Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days. [ Time Frame: 7 days ]
    A fever will be considered ≥38°C rectally or orally and ≥ 37.5°C axillary. Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days.


Secondary Outcome Measures :
  1. Cessation of fever within 24h following completion of treatment infusion (Length of infusion is 2h for infliximab and 8-10h for second IVIG) [ Time Frame: 24 h ]
    A fever will be considered ≥38°C rectally or orally and ≥ 37.5°C axillary. Cessation of fever within 24h following completion of treatment infusion (Length of infusion is 2h for infliximab and 8-10h for second IVIG).

  2. Change in white blood cell count (WBC), absolute neutrophil count (ANC), and high-sensitivity C-reactive protein (hsCRP, mg/L) concentration between baseline and 24 hours and 2 weeks following study treatment. [ Time Frame: 24h ]
    Change in white blood cell count (WBC), absolute neutrophil count (ANC), and high-sensitivity C-reactive protein (hsCRP, mg/L) concentration between baseline and 24 hours and 2 weeks following study treatment.

  3. Change in Zworst score between baseline and 2-week (± 4 days) echocardiograms [ Time Frame: 2 weeks ]
    Zworst score is defined as the largest internal diameter of either the right coronary or left anterior descending arteries normalized for body surface area and expressed as standard deviation units from the mean.

  4. Total number of fever days (24 hour period with a T≥38.0°C) from enrollment [ Time Frame: 7 days ]
    Determine the number of days a participant had a fever once the participant has been enrolled into the study.

  5. Duration of hospitalization [ Time Frame: 2 weeks ]
    How long a participant was hospitalized for.

  6. IVIG and infliximab infusion reactions and complications [ Time Frame: 7 days ]
    Determine any complications and/or reactions to each treatment.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible subjects will be as follows:

    1. 4 weeks to 17 years of age,
    2. fulfill the American Heart Association case definition for complete or incomplete KD,
    3. have had fever (T ≥38°C) for 3 to 10 days prior to initial IVIG treatment,
    4. have fever (T ≥38°C orally or rectally) between 36 hours and 7 days after end of the first IVIG infusion without other likely cause

Exclusion Criteria:

  1. Patient treated with infliximab or steroids for present illness (pts who received oral steroids as outpatients prior to KD diagnosis but who otherwise qualify for the study will not be excluded)
  2. Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065244


Contacts
Contact: Jane C Burns, MD 858-246-0155 jcburns@ucsd.edu
Contact: Adriana H Tremoulet, MD 858-246-0012 atremoulet@ucsd.edu

Locations
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Jane C Burns, MD    858-246-0155    jcburns@ucsd.edu   
Contact: Adriana H Tremoulet, MD    858-966-0012    atremoulet@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Jane C Burns, MD UCSD

Responsible Party: Jane C. Burns, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03065244     History of Changes
Other Study ID Numbers: UCSD 170064
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jane C. Burns, University of California, San Diego:
Kawasaki disease

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Infliximab
Immunoglobulins
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs